By James E. Valentine* & Alexander J. Varond – After giving us a few months to shake our sticks at the nearly 400-page 21st Century Cures Act (the Cures Act) discussion draft, the House Energy and Commerce Committee (the Committee) dropped a 200-page version that was …
By James C. Shehan – Of the three FDA final guidances that FDA recently released (here, here and here), the Questions and Answers guidance has received the most attention (see our previous post here). But our perusal of the ScientificConsiderations in Demonstrating Biosimilarity to a Reference …
By James E. Valentine* – In late April 2015, FDA’s Bioresearch Monitoring (“BIMO”) Program released its annual report on inspections from the previous fiscal year. BIMO is FDA’s multi-center compliance program for on-site inspections and data audits to monitor all aspects of FDA-regulated research, domestically and …
By Riëtte van Laack – The Court of Appeals for the Eleventh Circuit overturned a contempt order against Hi-Tech, Jared Wheat, Stephen Smith, and Dr. Terrill Mark Wright (“Hi-Tech”) because, according to the Court, the order was incorrectly premised on collateral estoppel. As we discussed in a …
By Karla L. Palmer - Earlier this week, the GAO released the Testimony of Marcia Crosse, Director, Health Care, before the Senate Caucus on International Narcotics Control. The statement, titled, “Controlled Substances: DEA Needs to Better Manage its Quota Process and Improve Coordination with FDA,” provides a …
By Andrew J. Hull* - On April 14, 2015, a federal judge in Iowa imposed a three-month term of imprisonment on two food executives, describing the period of imprisonment as “relatively small.” After a major Salmonella outbreak in August 2010 that left thousands of people sickened across …
By Ricardo Carvajal & JP Ellison – Last week, the federal district court judge presiding over industry’s challenge to Vermont’s law requiring GMO labeling issued a complex decision arising out of dueling motions. The State of Vermont had asked the court to dismiss the plaintiffs’ complaint, …
By Riëtte van Laack – Continuing its broad application of the consent decree in the action by the National Resource Defense Council against FDA (see our previous post here), FDA issued a proposal to amend the Tentative Final Monograph for Topical Antimicrobial Drug Products for Over-the-Counter …
By James C. Shehan – On April 28th, FDA finalized the three biosimilar guidances that it issued in 2012. Covering the topics of questions and answers regarding BPCIA implementation, scientific considerations in demonstrating biosimilarity, and quality considerations in demonstrating biosimilarity of proteins to reference products, the …
On April 27, 2015 the Drug Information Association journal, Therapeutic Innovation and Regulatory Science, published the findings of a study conducted by HP&M Attorneys Frank J. Sasinowski and James E. Valentine*, along with co-author, Erika B. Panico, RAC, head of U.S. Regulatory Affairs for Chiesi …
By Jennifer D. Newberger – As part of its 2014-2015 Strategic Priorities, the Center for Devices and Radiological Health (CDRH) committed to assuring the “appropriate balance between premarket and postmarket data collection to facilitate and expedite the development and review of medical devices.” By December 31, …
